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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceImpella 5.5 with SmartAssist
Generic NameTemporary non-roller type left heart support blood pump
ApplicantABIOMED, INC.
PMA NumberP140003
Supplement NumberS050
Date Received03/29/2019
Decision Date09/24/2019
Product Code OZD 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for various modifications to the Impella 5.0 System. The modified system is trademarked as “Impella 5.5 with SmartAssist System.”